A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia

Phase 1Enrolling By InvitationNCT07262268

Biohaven Therapeutics Ltd.5 enrolled

Overview

The purpose of this study is to test the potential benefits of BHV-7000 in reducing chronic pain in participants with IEM with a previously demonstrated gain of function mutation in the SCN9A gene.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Familial Erythromelalgia

Interventions

BHV-7000DRUG

Participants will take blinded investigational product (IP) orally once daily

PlaceboDRUG

Matching placebo taken orally once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Adult men and women between 18 to 75 years of age, inclusive, at time of consent with a diagnosis of inherited erythromelalgia with a previously characterized gain of function NaV1.7 mutation resulting in chronic pain. 2. Absence of concomitant mutation resulting in Kv7.2/7.3 gain of function. 3. Ability and willingness to adhere to the study procedures and complete accurate pain diaries 4. Stable background analgesic regimen for at least 30 days before screening and willingness to maintain the same analgesic regimen during the study period. Key Exclusion Criteria: 1. Any clinically significant laboratory abnormalities or clinically significant abnormalities on screening physical examination, vital signs, or ECG that, in the judgment of the principal investigator, indicates a medical problem that would preclude study participation. 2. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures

Locations (1)

Site-001

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Mean of the daily average maximum pain intensity scores collected every 2 hours.

Participants will be asked to record peak (worst) pain experienced in the previous 2 hours using an 11-point Likert scale (0-10) where 0=no pain and 10=worst possible pain

Time frame: The last 3 weeks of each 4-week crossover treatment period

Secondary Outcomes

The average weekly frequency of pain attacks on treatment vs. placebo

Participants will be asked to record occurrence of pain attacks

Time frame: The last 3 weeks of each 4-week crossover treatment period

The average duration of pain attacks on treatment vs. placebo

Participants will be asked to record the duration of their pain attacks

Time frame: The last 3 weeks of each 4-week crossover treatment period

The average peak severity of pain attacks on treatment vs. placebo

Participants will be asked to record the maximum severity of their pain attacks using an 11-point Likert scale (0-10) where 0=no pain and 10=worst possible pain.

Time frame: The last 3 weeks of each 4-week crossover treatment period

Safety and tolerability by reporting the frequency of unique participants with SAEs, severe AEs, AEs leading to discontinuation, deaths, and Grade 3-4 (CTCAE/DAIDS) laboratory abnormalities.

Measured by assessing the number of unique participants who experience treatment-emergent serious adverse events, adverse events leading to discontinuation, or moderate and severe adverse events.

Time frame: Up to 16 weeks

Data from ClinicalTrials.gov

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